Principal Quality Operations Engineer

Atri Cure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Afib affects more than 33 million people worldwide. Electrophysiologists and cardiothoracic surgeons around the globe use Atri Cure technologies for the treatment of Afib and reduction of Afib related complications. Atri Cure's Isolator Synergy Ablation System is the first medical device to receive FDA approval for the treatment of persistent Afib.

Atri Cure's Atri Clip Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide. Atri Cure's Hybrid AF Therapy is a minimally invasive procedure that provides a lasting solution for long-standing persistent Afib patients. Atri Cure's cryoICE cryoSPHERE probe is cleared for temporary ablation of peripheral nerves to block pain, providing pain relief in cardiac and thoracic procedures.

For more information, visit  or follow us on Twitter @Atri Cure.

We foster a culture of inclusion by embracing diverse experiences and individuals where everyone's authentic self is welcome. We offer supporting programs and resources that provide enriching and equitable opportunities for each person to contribute professionally and personally.

The Principal Quality Operations Engineer provides enterprise technical leadership and quality oversight for the manufacturing infrastructure, critical facility systems, and utility systems that support compliant, reliable production. This position is accountable for defining the quality strategy, governance, and lifecycle expectations for these systems, including risk assessment, system and process validation, change control, program management, and continuous improvement. This includes ownership of the policies, procedures, controls, and quality practices that govern these systems.

The role serves as a senior technical authority and trusted advisor, influencing cross-functional decisions to ensure facility and utility systems remain capable, controlled, inspection-ready, and aligned with applicable regulatory requirements and the Atri Cure Quality Management System.

• Lead the risk management program for critical facility and utility systems, including risk governance, escalation, timely investigation, and implementation of mitigations for identified risks, excursions, and quality issues.
• Define quality documentation expectations for facility and utility systems, including user needs, requirements, drawings, specifications, risk documentation, validation evidence, process controls, and related records.
• Establish quality strategies, Quality Plans, and validation master plans to guide large facility updates, utility changes, and critical system lifecycle management in alignment with Atri Cure validation and quality system policies.
• Lead strategic quality and facility implementation programs from initiation through completion, including priorities, deliverables, resource alignment, stakeholder engagement, risk-based decision-making, and executive-level status communication.
• Advise cross-functional teams on facility change requests, including line moves, equipment moves, utility additions, and related changes that support production operations and require quality impact assessment.
• Provide technical authority for qualification and validation strategies applied to critical facility, utility, equipment, monitoring, and data systems, including development, execution, review, and approval of IQ/OQ/PQ documentation and lifecycle activities.
• Lead validation and data integrity practices for systems that capture critical facility and utility data, including dashboards, alert and action limits, trend monitoring, and escalation of conditions…